JOB ID:164269
Job Type
Full Time
Functional Area
QA/Testing
Industry
Pharma/Biotech/Clinical Research
Education
Not Specified
Experience Required
15 - 17 Yrs
Key Skills Required
gmp requirements, product rejection, non-conformancesOther Skills Required
Areas of Responsibility
· Strong understanding of GMP requirements, exposure to Regulatory Inspection, and knowledge of international GMP requirements
· Experience in investigations related to complaint, product rejection, non-conformances, recalls, deviations, audits, regulatory inspections etc.
· Change management, quality risk management and Corrective Action and Preventive Action System throughout the Product Lifecycle
· Implementation and maintenance of effective QMS
Essential Job Functions:
· Establish road map for the remediation activities
· Assure timely resolution of issues/risks on remediation projects
· Facilitate preparation for Executive Steering Committee reviews
· Identify and list key activities for implementation, assign activity owners and target completion dates
· Act as the point of contact and communicate remediation status adequately to all team members
· Review the completed remediation actions for their adequacy and ensure it meets the agreed commitment
· Ensurin
... See MoreAreas of Responsibility
· Strong understanding of GMP requirements, exposure to Regulatory Inspection, and knowledge of international GMP requirements
· Experience in investigations related to complaint, product rejection, non-conformances, recalls, deviations, audits, regulatory inspections etc.
· Change management, quality risk management and Corrective Action and Preventive Action System throughout the Product Lifecycle
· Implementation and maintenance of effective QMS
Essential Job Functions:
· Establish road map for the remediation activities
· Assure timely resolution of issues/risks on remediation projects
· Facilitate preparation for Executive Steering Committee reviews
· Identify and list key activities for implementation, assign activity owners and target completion dates
· Act as the point of contact and communicate remediation status adequately to all team members
· Review the completed remediation actions for their adequacy and ensure it meets the agreed commitment
· Ensuring that key stakeholders are informed on relevant risks and implementing remediation plans
· Candidate needs to be dynamic with good communication and leadership qualities
· Performs all work in line with Sun Pharma values of Humility, Integrity, Passion and Innovation. Performs all work in accordance with all established regulatory and compliance and safety requirement
Educational Qualification: B.Pharm / M.Pharm
Experience: 15 to 17 Yrs See Less
Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over US$ 5.1 billion. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe.